Novartis voluntarily recalled a lot of its brand-name blood pressure drug Diovan (valsartan) after tests showed the tablets failed dissolution specifications, the FDA reported on August 8. The recall, initiated August 4, covers Diovan 160 mg, 90-tablet bottles, Lot AV5913C, expiring 06/2027; quantity available was not reported. The FDA labeled the event Class II on August 7, meaning temporary or medically reversible effects are possible though serious harm is unlikely. Patients with the listed lot should contact their pharmacy or healthcare provider for next steps.
Novartis Recalls Brand-Name Blood Pressure Drug Diovan After Dissolution Test Failure
blood pressure drug recallYevhen Maksymov/Getty Images
Novartis has voluntarily recalled its brand-name blood pressure medication Diovan (valsartan) after quality testing found the product failed dissolution specifications, the U.S. Food and Drug Administration (FDA) said in a report issued August 8.
Valsartan is an angiotensin II receptor blocker used to treat high blood pressure (hypertension) and certain heart conditions. The Mayo Clinic notes that valsartan "blocks a substance in the body that causes blood vessels to tighten" and is commonly prescribed alone or with other medicines for hypertension, heart failure, and to support recovery after a heart attack.
The recall was initiated on August 4 and affects a specific lot of Diovan. According to the FDA report, the issue is labeled as "Failed Dissolution Specifications," a manufacturing-quality problem that could mean tablets do not dissolve as expected for proper absorption. When dissolution is compromised, a medication may be absorbed more slowly or less completely, which can reduce effectiveness.
Recalled Product Details (per FDA):
- Product: Diovan (valsartan) 160 mg
- Pack Size: 90 tablets, Rx only
- Lot Number: AV5913C
- Expiration Date: 06/2027
- Quantity Available: Not Available
- Manufactured By: Patheon Manufacturing Services (North Carolina)
- Distributed By: Novartis (New Jersey office)
The FDA classified the recall as a Class II event on August 7, which indicates a mid-level severity: "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."
What Patients Should Do
- Check your prescription label for the lot number above. If it matches, contact your pharmacy or healthcare provider for guidance.
- Do not stop taking your medication without speaking to a healthcare professional — abrupt discontinuation of blood pressure drugs can be harmful.
- If you have the affected lot, your pharmacy can advise on returns, replacement options, or alternative medications.
- Contact the FDA MedWatch program or Novartis customer service if you experience unexpected symptoms or lack of expected blood pressure control.
This recall affects a specific lot only; patients with other lots or brands of valsartan are not necessarily impacted. Healthcare providers and pharmacies should review inventories and take appropriate action for the lot listed.
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